Pure Haven Essentials Spf-30

Pure Haven Essentials Spf-30
SPL v2
SPL
SPL Set ID 4bccc017-266d-11ce-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (60 mg) Zinc Cation
Inactive Ingredients
Aloe Vera Leaf Water Green Tea Leaf Medium-chain Triglycerides Cetostearyl Alcohol Cetearyl Glucoside Cetearyl Olivate Pumpkin Seed Oil Ethylhexyl Palmitate Glycerin Glyceryl Monostearate Helianthus Annuus Flowering Top Leuconostoc/radish Root Ferment Filtrate Almond Sesame Oil Sorbitan Olivate Cocoa Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-03-28

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:

For external use

  • For external use only. 
Directions:
  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every tow-hours.

- Immediately after swimming, sweating or towel drying.

Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. 

- Limit time in the sun, especially between 10am and 2pm.

- Wear long sleeve shirts, pants, hats and sunglasses.

- For childre under 6-months, consult with a physician.

Do Not Use 

on damaged or broken skin.

Active Ingredient

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Other Ingredients

Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Package Labeling:

other Information:
  • Protect this product from excessive heat and direct sunlight.
When Using This Product 

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

If product is swallowed, get medical attention or contact poison control center immediately.

Stop Use and Consult Physician 

if irritation or rash develops. 


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose

Sunscreen

Warnings:

For external use

  • For external use only. 
Directions:
  • Apply liberally 15-minutes before sun exposure.
  • Reapply:

- At least every tow-hours.

- Immediately after swimming, sweating or towel drying.

Spending time in the sun increase your risk of skin cancer and early skin aging . To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Sun protection measures. 

- Limit time in the sun, especially between 10am and 2pm.

- Wear long sleeve shirts, pants, hats and sunglasses.

- For childre under 6-months, consult with a physician.

Do Not Use  (Do not use )

on damaged or broken skin.

Active Ingredient

Titanium Dioxide (6.00%) Zinc Oxide (6.00%)

Other Ingredients

Aloe Barbadensis (Aloe vera) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Cucurbita Pepo (Pumpkin) Seed Oil, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Leuconostoc/Radish Root Ferment Filtrate, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Olivate, Theobroma Cacao (Cocoa) Butter, Xanthan Gum

Package Labeling:

other Information: (Other Information:)
  • Protect this product from excessive heat and direct sunlight.
When Using This Product  (When using this product )

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical attention or contact poison control center immediately.

Stop Use and Consult Physician  (Stop use and consult physician )

if irritation or rash develops. 


Advanced Ingredient Data


Raw Label Data

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